Trial data

[Ekkiemom]

Hi all....Hope everyone is well!..........I have not been able to find much info on trials for GT1a stage 3-4 fibrosis compensated  Sov/Rib SVR %'s, also for interferon intolerable prior treated.  I've seen a lot of info on treatment naive, cirrhotic, etc.  Can anyone point me to a good website with realistic cure rates......
Be well community

[Ekkiemom]

You go girl..... another sister Dragonslayer!  Hey what's that saying, There's power in numbers, right!  Again, will be sending good vibes out into the cosmos for you on a positive SVR...DRAGON CANT LIVE FOREVER!!
Keep looking forward
Be Well & Peace
Deb

[sue4hula]

Go get that dragon ladies!  It sounds like you have the right attitudes!

I feel the same way.  I am at the "waiting" stage, 5 1/2 weeks post treatment.  I'm hoping for SVR, but find encouragement in what's coming should I need to keep carrying the sword.  I've fought 3 times... All with Interferon and Ribavirin, the 2nd time with Victrelis ( now that was rough) and this time with the Sovaldi.  I will fight until this dragon is dead!  

Keep up the good fight!

[patra_]

Deb:  Hehehe!  Thanks for the wishes.  I do feel pretty positive about this one - but, who know?  What is, is.  I'll let you know the results.  

Did you say you have an appt to get results from Labs Friday.  Good vibes back at you!  Pat

[Ekkiemom]

Heya fellow Dragonslayer chick!!  LOL. Wow so Wednesday is the day. Wishing you heartfelt wishes for positive outcome.  Waiting jangles the nerves for sure. Sounds like u are getting along pretty well considering the Hmg, ur a strong one Pat. Don't over do it ok. Will also be sending positive vibes out into cosmos for you.  Keep us posted!
Peace
Deb

[Ekkiemom]

Hi Mac..thx for info...been keeping up with gilead didn't realize Merck was having trials.  Have the Dr.'s heading the trials mentioned anything about any resistance like in Olysio or have new med pharmas  figured out how to bypass that mess?  I'm really hopeful on the Tx I'm on dr. seems to think I will attain SVR at 12wks EOT as all of his treating patients have so far. I'm staying realistic too but staying positive the dragon is gonna lay on my sword when the time comes!  My hemoglobin is 11.7 which is good, Billi is WNL, ALT is 10pts H, of course gluc is 103 which I was told should be expected as VL goes down. Almost two yrs ago did INF/RIB/INCK....torturous at best, lasted 5 wks was so sick, blood transfusions,low potassium the list goes on. At that time VL was 13.5ml down 10mil. So this Tx 10ml to 17 in 3wks..just had labs drawn again last Thurs wtg for results come Fri maybe..keeping fingers crossed!
Let me know how your results come out. I will be sending positive vibes into the cosmos for you ✌️
Peace
Deb

[patra_]

Right there with you, Babe!  Doing my best to make this happen this time.  if it doesn't then I'll go for the next.  Before we knew help was available, I said there is no way I can do this and my husband, bless him, said we'll go mortgage the house, that should cover it.  If not we have some savings!  With that kind of back up, there is no way I could not accept the opportunity to slay this dragon now!  

Blue may be right in what he says, BUT, there are so many who ARE going on to SVR AND we are just talking about the posters on the Forum!  We have NO idea of all the people who have never even seen this site, or who did but did not post!  When you are looking at the numbers we see, I say, I cannot tell others to treat or not, but I can tell them that I simply cannot pass up this opportunity!

Like my dr says, if you SVR, then percentages don't matter.  If not you have given your liver a rest from the virus.  ALSO there is the next generation of meds to follow.  Of course, real world numbers don't match those hand picked for the trials, but, I believe the bio tech co.s have learned from that and they are testing on more realistic samples in these new trials.  Also, they are testing more genotypes.  We will see!

He (Blue)  acts like Gilead's Sol/Led is the Only option.  That is not true. BMS and AbbVie are two who are also close, one up for FDVA approval in November and one in December.  I have also read about a 4th company w/ their own combo but can't remember Co's name. I got that info from A biotrch newsletter  (Fierce BioTech - Sep 7th issue, I believe) who talks about what is coming up for consideration, what has been approved, etc, looking I guess, at investment opportunities.  

Anyway, onward and upward, DRAGONSLAYER!!  I am right with you - and ALL.    

Blue, I know you are just trying to warn people, and it is good to list your results and anything you can bacl up in print, but, let it go at that, please.  Each person needs to decide his/her own pathway, and we are not all the same so neither are our paths?

Horsepower (what a neat name):  You go, guy!  You give us great information!

E:  I am doing well.  had my Labs drawn completion of Week 13 (week ago today) and will see my Dr. Wednesday for results.  From the way I feel, my Hmg is staying in a 'bearable' range so shouldn't have to have the Provrit talk again.  I can get out and do things each day, use my walker to keep balance as I am weak from the normal fatigue  plus the Low (9.0) Hmg, but, wthe walker, I do get things done, and I count it all as exercise!  LOL.  He also ordered LFT and Viral Load, so I am really anxious to get my results!

ALL:  Keep on keeping on - we will ALL make it, and fairly soon.  I expect that down the road, there will be a vaccine which will prevent this monster from getting a hold on anyone!  We areTHE DRAGON SLAYERS AND THE TRAILBLAZERS, helping lead the way!!      Pat

E: I hope you are doing well.  You are closr to stabiilization point onHmg,

[FRED220]

Hector if I fail with S/O can I treat with the new med Sov/led ?

[FRED220]

Sovaldi/ledipasvir a protease inhibitor?

[Ekkiemom]

Back at ya

[hrsepwrguy]

:)

Wishing you all the best
Keith

[Ekkiemom]

Yes I know....I was just backing u up....sorry it looks the other way
Deb

[hrsepwrguy]

"liver brutalizing"

That statement belongs to bluemetal, I was asking for the info just as you are, however none has been produced.

Have a great day

[can-do-man]

We also have to keep in mind we here do not know the whole medical history or background of people who post here. Now if everyone was saying the same thing then of course that would mean something. But I have seen both SVR's and failures. Some with no sides and some that have them. Just like any disease one shoe does not fit all.

One thing is for certain every time a new drug comes out so does the hype. It happened with the PI's and then with this set. Now it starting with the newer drugs due out. All I can say if your cirrhotic or close to it then TREAT because doing nothing but "waiting" is not curing anything.

[bluemetal]

Everyone whos posted in this forum during the past 3 months regarding their painful side effects and failed tx and relapses and continued cirrhosis, even tests showing worsened fibrosis following tx is sufficient evidence to suggest that the sovaldi/ledisprvir combo, which is practically the same protease inhibitor of all new DAA's will have similar results. The only difference is that the sovaldi/led combo is tailored specifically for gt1a's which means gt1a's are going to be of the highest group enduring this regime. Again, I do not place much credence in "clinical trial" puiblications as these are now shown to be much different than real world facts. This of course is only my educated opinion and not meant to dissuade anyone from following their doctors advice. As far as this new combo being added with the third DAA- GS9453, it stands to reason based upon what weve seen in real world results with previous tx's that a third DAA will have greater effect but with greater strain on the liver. Im not going to post "clinical data" for reference at this time because like I said, such doesnt coincide hardly at all with what is being seen.

[patra_]

E:  If I remember correctly you should be done w/your meds approximately the same time I am.    don't stress over 'real world' percentages - what is, is, However, as my Dr says, if you are in the % cured, percentages don't matter,  AND, it is nice to know, you you case, there are approximately 3 new treatments waiting in the wings, if needed.

As always, Hector gave you very good information.  Blue is right that ALL of these protocols are less successful in the real world, BUT that is no reason not to try.  Plus, even if you are not SVR'd this time, at least you are giving your liver a rest from the virus, and that can keep the Fibrosis from progressing.

Keep on keeping on, don't stress - that is just counter productive.  This dragon is going down!!!  : -). Pat

[hrsepwrguy]

"Gilead tx will also have liver-brutalizing effects in destroying the virus. And if the Sovaldi/Ledisprvir combo is not added to the third DAA for a tx period of 24 weeks instead of 12 than chances of  permanant SVR are even less for gt1a's."

Could you please post some peer reviewed data to support your claim, would love to read it.

Have a great day

[bluemetal]

As Mike716 revealed in his post, and Im in full agreement as a gt1a cirrhotic patient who just ended treatment on Sovaldi/olysio before finishing, its in your best interest to wait a little longer for the sovaldi/ledisprvir combo in Nov-Dec.  To begin with REAL world results on all treatments are not even close to the results being recorded and published by clinic trial people whos primary interest is to market these drugs. Its for this reason that anyone following these "clinical trial " results as a guideline in determining their best course of tx aremisleading themselves. Im only stating an educated  opinion basedon experiance as well. And Im suggesting the Sovaldi/Ledisprvir tx not because of clinical trial data but rather because its really theONLY safe option left for those ofus in this catagory (gt1a F-4). I remain certain that this new Gilead tx will also have liver-brutalizing effects in destroying the virus. And if the Sovaldi/Ledisprvir combo is not added to the third DAA for a tx period of 24 weeks instead of 12 than chances of  permanant SVR are even less for gt1a's.

[mac790]

Hello, I am 1a, Stage 5. I have been participating in a clinical trial sponsored by Merck, Phase III. I would expect, with the SVR rates already collated and published for this single pill a day therapy (a direct acting antiviral, and new generation of protease inhibitor), to be fast tracked by the FDA and on the market by the end of next year. If you can hold off on treating, please wait. Merck is not the only big pharma mfr. to have drugs in either Phase II or III trials, all with phenomenal SVR rates. Due to screw ups at the lab Merck uses, I don't know my Week 4 or 6 viral load counts. I can tell you that in 7 days, it dropped from 585,000+ to 396. The published SVR rates, even with cirrhotic persons, is 97%+. No interferon, no ribavirin. One pill a day for 12 weeks. Some in my study got the 16 week treatment arm, but the studies I have quoted are all after just 84 pills. The future is looking extremely bright, if you can hang in there. My trial hospital just bought a brand new "FibroScan" machine, which gives 3D, extremely thorough investigative views the entire liver, not just selected cirrhotic regions of the liver. It is so accurate that it will probably replace needle biopsy as the" gold standard" very, very soon.There may still be some reasons for needle biopsies in the future, I'm not an MD, so I can't definitively state there will be no need for them at all. Please do not lose sleep over your Stage 4 Dx. If your hemoglobin and bilirubin are WNL, and you don't have esophogeal varices, your liver is still doing its' job well. These Stage 3/4... Dxs are very subjective, and can vary significantly between hepatologists. Just realize it is present in some stage or other, and don't do anything to aggravate it. I would love to see you get into a clinical trial of these drugs such as I mentioned. I think the trials may be done on Gilead's next drug, however. Please refer to www.clinicaltrials.gov to see if there is a Phase III trial recruiting near you. If you go to www. healio.com,click through to the GI section, and search for "EASL 2014" or "C-Worthy", you can see for yourself the outstanding, almost unblievable results these new generation meds are having. Regardless if you are a previous null responder to other therapies, or cirrhotic. I failed miserably the "Pegasys" combo therapy in 2009.  Any questions, please feel free to drop me a line or post it. I will finally discover my viral load on 10-3. If that lab Merck insists upon using ( this trial is being run at a world class institution, right up there with Mass General and Johns Hopkins) screws up a third viral load in a row, my Hepatologist's head ( who is running the trial) will explode. Along with mine. Hang in there, the technology is literally improving daily. mac790
P.S. The only downside to these new meds is the cost. The estimated asking price for this drug I am using will be $85,000 for a 12 week course of therapy. We can only hope that the arrival of other, just as good or better meds on the market, plus the pressure from insurance companies and Medicare, will lower the cost of these miracle drugs. Best of luck to you.

[HectorSF]

Be well.

Hector

[Ekkiemom]

I must of misunderstood the dr. about the bridging. Ok I think I understand a lot more...as always good health to you!
Deb

[HectorSF]

There must be some misunderstanding...
Stage 3 fibrosis is bridging fibrosis.
Stage 4, cirrhosis, is beyond bridging fibrosis including collagen completely surrounding the entire expanding nodule.
Stage 3-4 is more advanced fibrosis which includes some cirrhosis
So I am not sure what you mean by "no bridging" when your biopsy result?

Liver fibrosis is the scarring process that is the liver’s response to injury. In the same way as skin and other organs heal wounds by depositing  collagen and other matrix matter so the liver repairs injury through creating  of new collagen. Over time this process can result in cirrhosis of the liver, in which the architectural organization of the functional units of the liver becomes so disrupted that blood flow through the liver and liver function become disrupted.

The main factor in staging fibrosis is the length in expansion of fibrotic areas between portal tracts.

Stage 0 no fibrosis
Stage 1 none or mild peri-portal fibrosis
Stage 2 peri-portal fibrosis with/without extension and portal-portal bridging
Stage 3 multiple portal-central bridges but no nodular formation
Stage 4 cirrhosis, with bands of surrounding tissue around the expanding nodule

Take care.
Hector

[Ekkiemom]

Hey Hector......Yes I did have the biop stage 3-4 fibrosis no bridging, that is why I am confused about the numbers.  I'm grateful we have the drugs we do. Just feel need to be informed. I'm gonna beat the reaper this time.
Thx again for the info, always appreciated.  Best to you
Deb

[HectorSF]

Don't take my word for it, all of the data is in the clinical trial results and commentary by the leading hepatitis C doctors are available online for all to read. All that I said is common knowledge in the hepatology medical community. It is also incorporated into the AASLD/IDSA hepatitis C treatment guidelines. http://www.hcvguidelines.org/

"my gastro said I didn't have cirrhosis but from what I am reading  F3 is fibrosis and F4 is cirrhosis?"
Didn't you have a liver biopsy or other test to know what stage liver disease you have? Stage of liver disease greatly effects SVR rates. If cirrhotic SVR rates are much lower than with lesser liver disease.

It is your doctor's job to know what the best hepatitis C treatments are currently is for each individual based on their medical history and your current health status. They should be at minimum with the AASLD/IDSA "Recommendations for Testing, Managing, and Treating Hepatitis C" that discuss treatments for different types of patients including the pros and cons.

"around these parts is I was told I will be able to treat with the new meds coming in the next few months if the scenerio is not in my favor come mid Jan..correct?  "

Yes that is what many, including myself, are planning to do should we fail our current treatment. I am treating now with Sovaldi/Olysio + Ribavirin so if I fail this treatment I will treat with one of the coming better treatments that will be available early next year that is more effective for my particular post transplant situation. This is what many of us have done before after failing previous treatments. As older treatments success rates were generally poor many of us have treated multiple times and will continue to do so until cured.

We are not statistic, what our outcome from treatment will be is unpredictable. There are no guarantees.
You have already started treatment so hope for the best. That is all any of us can hope for. There is no 100% cure yet.

Stay hopeful. We don't have control over the outcome. So no point worrying about what we can't control as it won't change the outcome.
Be well.
Hector

[Ekkiemom]

Ok.....so...now I'm really confused...my gastro said I didn't have cirrhosis but from what I am reading  F3 is fibrosis and F4 is cirrhosis?  Another thing I was told by him was that because sovaldi is so powerful that there is no need to worry about the IL28B C/C or Q80K polymorphism. You only have to worry about that if doing the Tx with Olysio. That is why he had me on Sov I imagine. I'm not at all doubting what you are saying Hector just trying to make sense of the information. My VL was 10 mil @ SOT I know I have mentioned this before, forgive my repetitiveness.  I was given the option of waiting until the coformulated pill came out or start with Sov/Rib. I chose the earlier tx. I kept reading that after Gilead submitted their NDA there was talk of the expense and no one was going to back it, needless to say I was a little scared and opted torte a sooner than later.  Another point I would like to ask you since you are the HEP C GURU around these parts is I was told I will be able to treat with the new meds coming in the next few months if the scenerio is not in my favor come mid Jan..correct?  So I have an 80%  or 92% chance of SVR....apologize for so many darn ?'s. Oh my test@ 3 wks

Using the COBAS (R)ampliPrep/COBAS(R)TaqMan(R)HCV Test v2.0
HCV RNA QUANTITATIVE REAL TIME PCR 17. H.      <15IU/mL
  ".            ".                            ".                        1.23H.     <1.18 LogIU/mL

He said he used the more sensitive test that was the <43 so he considered me UND @ 3wks.  This past Thurs I had 7wk labs done he did another VL as well.   I'm guessing that I won't be seeing him until EOT for another lab. Is that right?

Kinda feel like a late bloomer as far as getting this info out to ask more I depth questions but couldn't quite pull the thoughts together enough.  Feeling like some fog has passed for a moment so i better do it....
Thx for listening, I'll stop rambling now LOL
Be Well and Keep the Faith
Deb